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. 2021 May 10;2021(5):CD013620. doi: 10.1002/14651858.CD013620.pub2

Stapleton 1986.

Study characteristics
Methods Study objective: not provided
Study design: randomised controlled trial
Study grouping: parallel group
Duration of follow‐up: not described
Number of arms: 3
Single centre or multi‐site: single centre
Study start date and end date: not described
Setting: acute care setting
Participants Baseline characteristics
Inclusion criteria: female elderly patients with fractured neck of femur, without existing pressure ulcers, Norton score 14 or less
Exclusion criteria: patients did not meet the criteria, or admitted with existing pressure sores
Sex (M:F): all female patients (0:32 in large cell Ripple; 0:34 in polyether foam pad; 0:34 in Spenco pad)
Age (years): mean 81 across groups
Baseline skin status: mean Norton score 12.0 in large cell Ripple; 12.8 in polyether foam pad; 12.9 in Spenco pad; no existing pressure ulcers
Group difference: no difference
Total number of participants: n = 100
Unit of analysis: individuals
Unit of randomisation (per patient): individuals
Interventions Intervention characteristics
Large Cell Ripple (Talley)
  • Description of interventions: Large Cell Ripple (Talley)

  • NPIAP S3I classification: powered, alternating pressure (active) air surface

  • Co‐interventions: not described

  • Number of participants randomised: not described

  • Number of participants analysed: n = 32


Polyether foam pad
  • Description of interventions: Polyether foam pad 2 feet x 2 feet x 3‐inch thickness

  • NPIAP S3I classification: non‐powered, reactive foam surface

  • Co‐interventions: not described

  • Number of participants randomised: not described

  • Number of participants analysed: n = 34


Spenco pad
  • Description of interventions: Spenco pad

  • NPIAP S3I classification: non‐powered, reactive fibre surface

  • Co‐interventions: not described

  • Number of participants randomised: not described

  • Number of participants analysed: n = 34

Outcomes Proportion of participants developing a new pressure ulcer
  • Outcome type: binary

  • Time points: not reported

  • Reporting: partially reported

  • Measurement method (e.g. scale, self‐reporting): graded by Borders (Grade A superficial/blister; Grade B a break in skin but no crater; Grade C a break in skin with crater; Grade D blackened tissue)

  • Definition (including ulcer stage): patients with the development of pressure ulcers graded by Borders

  • Dropouts: not described.

  • Notes (e.g. other results reported): 12 of 34 in Spenco (2 Grade A/ 8 Grade B/ 2 Grade C/ 0 Grade D); 14 of 34 in Foam (1/5/3/5); 11 of 32 in Ripple (2/9/0/0)


Time to pressure ulcer development
  • Reporting: not reported


Support‐surface‐associated patient comfort
  • Reporting: not reported


All reported adverse events using allocated support surfaces
  • Reporting: not reported


Health‐related quality of life (HRQOL)
  • Reporting: not reported


Cost‐effectiveness
  • Reporting: not reported

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “patients for the first two groups were selected by lottery, and thereafter patients were allocated to each group systematically, in rotation”
Comment: unclear risk of bias because it is unclear if a proper randomisation method was applied.
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: no information provided.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: no information provided.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: no information provided.
Selective reporting (reporting bias) Unclear risk Comment: no information provided.
Other bias Unclear risk Comment: no information provided.